Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT03520205
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2018-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015775', 'term': 'Fractures, Stress'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2018-04-15', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Interleukin-6 at 24 hours after abdominal insufflation', 'timeFrame': 'Before procedure, at the end of surgery, and 24 hours after abdominal insufflation', 'description': 'Measure by ELISA'}, {'measure': 'Cumulative morphine requirement at 2 hours, 6 hours, 12 hours, 24 hours postoperative', 'timeFrame': '2 hours, 6 hours, 12 hours, 24 hours.', 'description': 'Cumulative morphine consumption at each time point in 24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Patient Controlled Analgesia at 2, 6, 12 and 24 hours after procedure', 'timeFrame': '2, 6, 12, and 24 hours after procedure', 'description': 'Measure by how many times patient use morphine PCA analgesia'}, {'measure': 'Change from Baseline Pain Intensity at 2, 6, 12, and 24 hours after procedure', 'timeFrame': '2, 6, 12, and 24 hours after procedure', 'description': 'Measured by Numerical Rating Scale'}, {'measure': 'Change from Baseline Blood Glucose at 2 hours after abdominal insufflation', 'timeFrame': 'Before procedure and 2 hours after abdominal insufflation', 'description': 'Measured by finger-stick blood sample'}, {'measure': 'Change from Baseline Blood pressure', 'timeFrame': 'Intraoperative and 24 hours', 'description': 'Measured by non-invasive blood pressure monitoring at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery'}, {'measure': 'Change from Baseline Mean Arterial Pressure', 'timeFrame': 'Intraoperative and 24 hours', 'description': 'Measured by non-invasive blood pressure monitoring at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery'}, {'measure': 'Change from Baseline Cardiac Index', 'timeFrame': 'Intraoperative and 24 hours', 'description': 'Measured by cardiometry ICON® at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery'}, {'measure': 'Change from Baseline Heart Rate', 'timeFrame': 'Intraoperative and 24 hours', 'description': 'Measured by pulse oximetry at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery'}, {'measure': 'Change from Baseline hs-CRP at 48 hours after abdominal insufflation', 'timeFrame': 'Before procedure, at the end of surgery, and 48 hours after abdominal insufflation', 'description': 'Measured with ELISA'}, {'measure': 'Time to first morphine requirement', 'timeFrame': '24 hours', 'description': 'Duration from end of anesthesia until first attempt of morphine requirement in minutes'}, {'measure': 'Total bupivacaine used in 24 hours', 'timeFrame': '24 hours', 'description': 'Total bupivacaine used until 24 hours postoperatively'}, {'measure': 'Change from baseline motor block at 2, 6, 12, and 24 hours after anesthesia recovery', 'timeFrame': '2, 6, 12, and 24 hours after procedure', 'description': 'Measured by Bromage score'}, {'measure': 'Number of participants with paresthesia after procedure', 'timeFrame': '24 hours', 'description': 'in percentage'}, {'measure': 'Duration of urinary catheter', 'timeFrame': '24 hours', 'description': 'in hours'}, {'measure': 'Level of sensory block after procedure', 'timeFrame': '24 hours', 'description': 'Measured by cold and pin prick sensation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stress response', 'kidney donor', 'Cellular Imunological Function', 'quadratus lumborum block', 'numerical rating scale', 'morphine patient controlled analgesia'], 'conditions': ['Renal Transplant Donor of Left Kidney']}, 'referencesModule': {'references': [{'pmid': '23150820', 'type': 'BACKGROUND', 'citation': 'Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23.'}, {'pmid': '17944639', 'type': 'BACKGROUND', 'citation': 'SarinKapoor H, Kaur R, Kaur H. Anaesthesia for renal transplant surgery. Acta Anaesthesiol Scand. 2007 Nov;51(10):1354-67. doi: 10.1111/j.1399-6576.2007.01447.x.'}, {'pmid': '20508268', 'type': 'BACKGROUND', 'citation': 'Minnee RC, Idu MM. Laparoscopic donor nephrectomy. Neth J Med. 2010 May;68(5):199-206.'}, {'pmid': '15136930', 'type': 'BACKGROUND', 'citation': 'Buunen M, Gholghesaei M, Veldkamp R, Meijer DW, Bonjer HJ, Bouvy ND. Stress response to laparoscopic surgery: a review. Surg Endosc. 2004 Jul;18(7):1022-8. doi: 10.1007/s00464-003-9169-7. Epub 2004 May 12.'}, {'pmid': '10927999', 'type': 'BACKGROUND', 'citation': 'Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.'}, {'pmid': '25829908', 'type': 'BACKGROUND', 'citation': 'Das W, Bhattacharya S, Ghosh S, Saha S, Mallik S, Pal S. Comparison between general anesthesia and spinal anesthesia in attenuation of stress response in laparoscopic cholecystectomy: A randomized prospective trial. Saudi J Anaesth. 2015 Apr-Jun;9(2):184-8. doi: 10.4103/1658-354X.152881.'}, {'pmid': '24974901', 'type': 'BACKGROUND', 'citation': 'Gulyam Kuruba SM, Mukhtar K, Singh SK. A randomised controlled trial of ultrasound-guided transversus abdominis plane block for renal transplantation. Anaesthesia. 2014 Nov;69(11):1222-6. doi: 10.1111/anae.12704. Epub 2014 Jun 28.'}, {'pmid': '28154824', 'type': 'BACKGROUND', 'citation': 'Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.'}, {'pmid': '14558706', 'type': 'BACKGROUND', 'citation': 'Skrekas G, Papalois VE, Mitsis M, Hakim NS. Laparoscopic live donor nephrectomy: a step forward in kidney transplantation? JSLS. 2003 Jul-Sep;7(3):197-206.'}, {'pmid': '17112833', 'type': 'BACKGROUND', 'citation': 'Oyen O, Scholz T, Hartmann A, Pfeffer P. Minimally invasive kidney transplantation: the first experience. Transplant Proc. 2006 Nov;38(9):2798-802. doi: 10.1016/j.transproceed.2006.08.102.'}, {'pmid': '27578313', 'type': 'BACKGROUND', 'citation': 'Jianda X, Yuxing Q, Yi G, Hong Z, Libo P, Jianning Z. Impact of Preemptive Analgesia on inflammatory responses and Rehabilitation after Primary Total Knee Arthroplasty: A Controlled Clinical Study. Sci Rep. 2016 Aug 31;6:30354. doi: 10.1038/srep30354.'}, {'pmid': '26604816', 'type': 'BACKGROUND', 'citation': 'Southworth SR, Woodward EJ, Peng A, Rock AD. An integrated safety analysis of intravenous ibuprofen (Caldolor((R))) in adults. J Pain Res. 2015 Oct 23;8:753-65. doi: 10.2147/JPR.S93547. eCollection 2015.'}, {'pmid': '24287348', 'type': 'BACKGROUND', 'citation': 'Spiro MD, Eilers H. Intraoperative care of the transplant patient. Anesthesiol Clin. 2013 Dec;31(4):705-21. doi: 10.1016/j.anclin.2013.09.005. Epub 2013 Nov 6.'}, {'pmid': '18555130', 'type': 'BACKGROUND', 'citation': 'Bhosale G, Shah V. Combined spinal-epidural anesthesia for renal transplantation. Transplant Proc. 2008 May;40(4):1122-4. doi: 10.1016/j.transproceed.2008.03.027.'}, {'pmid': '31805855', 'type': 'DERIVED', 'citation': 'Aditianingsih D, Pryambodho, Anasy N, Tantri AR, Mochtar CA. A randomized controlled trial on analgesic effect of repeated Quadratus Lumborum block versus continuous epidural analgesia following laparoscopic nephrectomy. BMC Anesthesiol. 2019 Dec 5;19(1):221. doi: 10.1186/s12871-019-0891-7.'}], 'seeAlsoLinks': [{'url': 'http://medind.nic.in/iad/t03/i6/iadt03i6p427.pdf', 'label': 'STRESS RESPONSE AND ANAESTHESIA ALTERING THE PERI AND POST-OPERATIVE MANAGEMENT'}, {'url': 'http://www.ijcem.com/files/ijcem0028816.pdf', 'label': 'Efficacy of parecoxib on the level of IL-6, CRP, and postoperative pain relief after percutaneous nephrolithotomy'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor', 'detailedDescription': 'Sixty-two subjects were given informed consent before enrolling the study and randomized into two groups; quadratus lumborum block and epidural. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse-oxymetry were set on the subjects in the operation room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 1-2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with Atracurium 0.5mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. On quadratus lumborum block group, bilateral block using ultrasound will be performed with stimuplex 100mm needle with 20 cc of bupivacaine 0.25% as regimen. On epidural group, epidural catheter was inserted under general anaesthesia on left lateral decubitus position (5 cm depth inside the epidural space) at level Th10-Th11. The catheter insertion was confirmed with vacuum aspiration and negative test-dose. Before first incision, patient will be given continuous epidural Bupivacaine 0.25% 6 mL/hour. Blood sample was drawn for interleukin-6, blood glucose, and c-reactive protein as baseline data. After surgery, patient were extubated until fully conscious and can follow command verbally. Patient will be transported in recovery room post operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kidney donor patients undergoing laparoscopic nephrectomy\n* Body mass index below 30\n* Duration of surgery 4 to 6 hours\n* Patients who agreed to participate in this study and sign informed consent.\n\nExclusion Criteria:\n\nHave contraindication for quadratus lumborum block\n\n* Have contraindication for epidural\n* Previous history of local anesthetic drug allergy\n* inability to communicate'}, 'identificationModule': {'nctId': 'NCT03520205', 'briefTitle': 'Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Comparison Between Quadratus Lumborum Block and Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor', 'orgStudyIdInfo': {'id': 'IndonesiaUAnes021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Quadratus Lumborum Block', 'description': 'Patient will receive quadratus lumborum block', 'interventionNames': ['Procedure: Quadratus Lumborum Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Epidural', 'description': 'Patient will receive epidural anesthesia', 'interventionNames': ['Procedure: Continuous Epidural']}], 'interventions': [{'name': 'Quadratus Lumborum Block', 'type': 'PROCEDURE', 'description': 'Bilateral block using ultrasound will be performed before surgery and after surgery on patient using Stimuplex 100mm needle with Bupivacaine 0.25% 0.4 mL/kg, maximum dose 25 mL each side under general anaesthesia', 'armGroupLabels': ['Quadratus Lumborum Block']}, {'name': 'Continuous Epidural', 'type': 'PROCEDURE', 'description': 'Patient will be given 6 mL/hour of Bupivacaine 0.25% for intraoperative analgesia and continued epidural 6 mL/hour Bupivacaine 0,125% as postoperative analgesia in 24 hours.', 'armGroupLabels': ['Continuous Epidural']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo Central National Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist Consultant', 'investigatorFullName': 'Aida Rosita Tantri', 'investigatorAffiliation': 'Indonesia University'}}}}